Suvardio Plus

Package Leaflet: Information for the Patient

Suvardio Plus, 5 mg + 10 mg, tablets

Suvardio Plus, 10 mg + 10 mg, tablets

Suvardio Plus, 20 mg + 10 mg, tablets

Rosuvastatin + Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Suvardio Plus and what is it used for
• 2. Important information before taking Suvardio Plus
• 3. How to take Suvardio Plus
• 4. Possible side effects
• 5. How to store Suvardio Plus
• 6. Contents of the pack and other information

1. What is Suvardio Plus and what is it used for

Suvardio Plus contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines known as statins, and the other active substance is ezetimibe. Suvardio Plus is used to reduce the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides, and to increase the level of "good" cholesterol (HDL cholesterol). The medicine works by reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by the body.

In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if left untreated, it can cause fatty deposits to build up in the walls of blood vessels, leading to their narrowing. As a result of the narrowing, it is possible for the blood vessel to become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.

Suvardio Plus is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. While taking this medicine, it is essential to continue with a low-cholesterol diet.

The doctor may prescribe Suvardio Plus if the patient is already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine.

The medicine is used in patients:

• with high cholesterol levels in the blood (primary hypercholesterolemia)
• with heart disease - Suvardio Plus reduces the risk of heart attack, stroke, the need for surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

Suvardio Plus does not help with weight loss.

2. Important information before taking Suvardio Plus

When not to take Suvardio Plus

• if the patient is allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver disease
• if the patient has severe kidney problems
• if the patient experiences recurring, unexplained muscle pain (myopathy)
• if the patient is taking a medicine containing cyclosporin (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Suvardio Plus, they should stop taking the medicine immediately and inform their doctor. While taking Suvardio Plus, women should avoid becoming pregnant, using effective methods of contraception (see "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or if the patient is unsure), they should consult their doctor.

Warnings and precautions

Before taking Suvardio Plus, the patient should discuss it with their doctor or pharmacist if:

the patient has kidney problems;

the patient has liver problems;

the patient has experienced recurring or unexplained muscle pain, has a history of muscle disorders, or has had previous muscle problems related to taking other cholesterol-lowering medicines. If the patient experiences unexplained muscle pain, especially if accompanied by a feeling of illness or fever, they should contact their doctor immediately. The patient should also inform their doctor or pharmacist about persistent muscle weakness;

the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4);

the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Suvardio Plus for the patient;

the patient is taking antiviral medicines, including those used to treat HIV or hepatitis C, such as ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (see "Suvardio Plus and other medicines");

the patient has severe respiratory failure;

the patient is taking other cholesterol-lowering medicines (fibrates) (see "Suvardio Plus and other medicines");

the patient regularly consumes large amounts of alcohol;

the patient has been diagnosed with hypothyroidism (underactive thyroid);

the patient is over 70 years old (as the doctor will need to choose a suitable dose of Suvardio Plus);

the patient is taking or has taken fusidic acid orally or by injection in the last 7 days. The doctor will inform the patient when it is safe to resume taking Suvardio Plus. Taking Suvardio Plus and fusidic acid at the same time may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis).

the patient has ever experienced a severe skin rash or skin peeling, blisters, or ulcers in the mouth, throat, nose, genitals, or eyes after taking rosuvastatin or similar medicines. Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If the patient experiences any of the symptoms described in section 4, they should stop taking Suvardio Plus and contact their doctor immediately.

If any of the above situations apply to the patient (or if the patient is unsure), they should consult their doctor or pharmacist before starting Suvardio Plus.

A small number of people taking statins may experience liver problems. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests while taking Suvardio Plus. It is essential for the patient to attend these tests as scheduled.

While taking this medicine, the doctor will closely monitor the patient's condition if they have diabetes or are at risk of developing it. There is a high risk of developing diabetes if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.

If the patient is hospitalized or treated for another condition, they should inform the medical staff that they are taking Suvardio Plus.

Children and adolescents

Suvardio Plus is not recommended for use in children and adolescents under 18 years of age.

Suvardio Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor about taking any of the following medicines:

• cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection of the transplanted organ. Cyclosporin increases the effect of rosuvastatin taken at the same time). Do not take Suvardio Plus while taking cyclosporin.
• anticoagulants, such as warfarin, acenocoumarol, or fluindione (taking Suvardio Plus at the same time may increase the anticoagulant effect, with a higher risk of bleeding), ticagrelor, or clopidogrel.
• other cholesterol-lowering medicines, such as fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this class). Taking Suvardio Plus at the same time increases the effect of rosuvastatin.
• colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works.
• medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines may reduce the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Taking Suvardio Plus at the same time reduces the effect of rosuvastatin.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to stop taking Suvardio Plus temporarily. The doctor will inform the patient when it is safe to resume taking Suvardio Plus. Taking Suvardio Plus and fusidic acid at the same time may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis).
• oral contraceptives (birth control pills). Taking Suvardio Plus at the same time increases the level of sex hormones released from the pill.
• hormone replacement therapy (increasing hormone levels in the blood).
• regorafenib (used to treat cancer).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If the patient is to be hospitalized or treated for another condition, they should inform the medical staff that they are taking Suvardio Plus.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Suvardio Plus must not be takenif the patient is pregnant, trying to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Suvardio Plus, they should stop taking the medicine immediatelyand inform their doctor. While taking Suvardio Plus, women should use effective methods of contraception (see "Pregnancy and breastfeeding").

Breastfeeding

Suvardio Plus must not be takenwhile breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Suvardio Plus is unlikely to affect the patient's ability to drive or use machines. However, the patient should be aware that Suvardio Plus may cause dizziness. In this case, before driving or using machines, the patient should consult their doctor.

Suvardio Plus contains sodium and lactose

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Suvardio Plus

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

While taking Suvardio Plus, the patient should continue with a low-cholesterol diet and maintain physical activity.

The recommended daily dose for adults is one tablet of the prescribed strength.

Suvardio Plus should be taken once a day.

The medicine can be taken at any time of day, with or without food. The tablets should be swallowed whole, with a glass of water.

The medicine should be taken at the same time every day.

Suvardio Plus is not suitable for starting treatment. If treatment is started or the dose needs to be changed, the patient should take each active substance separately and only switch to Suvardio Plus once the doses have been established.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to monitor their cholesterol levels and ensure they are within a healthy range.

Taking a higher dose of Suvardio Plus than recommended

If the patient takes more Suvardio Plus than they should, they should contact their doctor or the nearest hospital emergency department, as medical attention may be necessary.

Missing a dose of Suvardio Plus

If the patient misses a dose, they should take the next tablet at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping Suvardio Plus treatment

The patient should inform their doctor if they want to stop taking Suvardio Plus. After stopping Suvardio Plus, the patient's cholesterol levels may rise again.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Suvardio Plus can cause side effects, although not everyone gets them.

It is essential for the patient to know what side effects can occur with Suvardio Plus.

If the patient experiences any of the following reactions, they should stop taking the medicineand seek medical help immediately:

Suvardio Plus and seek medical help immediately:

• swelling of the face, lips, tongue, and/or throat, which may make breathing or swallowing difficult,
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
• muscle rupture
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should contact their doctor immediatelyif they experience any unusual, persistent muscle pain. This condition can rarely progress to life-threatening muscle damage (known as rhabdomyolysis), causing illness, fever, and kidney problems.

To determine the frequency of side effects, the following classification has been used:

• very common (may occur more frequently than 1 in 10 people)
• common (may occur less frequently than 1 in 10 people)
• uncommon (may occur less frequently than 1 in 100 people)
• rare (may occur less frequently than 1 in 1,000 people)
• very rare (may occur less frequently than 1 in 10,000 people), including isolated cases

Common side effects

headache

constipation

nausea

muscle pain

feeling weak

dizziness

diabetes - this is more likely to occur in patients with high blood sugar and fat levels, who are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

stomach pain

diarrhea

bloating (excess gas in the intestines)

feeling tired

increased results of some blood tests that assess liver function (aminotransferase activity)

Uncommon side effects

rash, itching, hives

increased protein in the urine, which usually resolves on its own without the need to stop taking Suvardio Plus tablets

increased results of certain blood tests that assess muscle condition (creatine kinase activity)

cough

indigestion

heartburn

joint pain

muscle spasms

neck pain

decreased appetite

pain

chest pain

hot flashes

high blood pressure

tingling

dry mouth

stomach inflammation

back pain

muscle weakness

pain in the arms and legs

swelling, especially of the hands and feet

Rare side effects

pancreatitis, causing severe stomach pain that may radiate to the back

decreased platelet count

Very rare side effects

jaundice (yellowing of the skin and eyes)

liver inflammation

trace amounts of blood in the urine

nerve damage in the legs and arms (e.g., numbness)

memory loss

breast enlargement in men (gynecomastia)

Side effects with unknown frequency

shortness of breath

swelling

sleep disorders, including insomnia and nightmares

sexual disorders

depression

breathing difficulties, including persistent cough and/or shortness of breath or fever

tendon damage

persistent muscle weakness

gallstones or gallbladder inflammation (which may cause stomach pain, nausea, vomiting)

myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing)

myasthenia gravis (a disease that causes muscle weakness in the eyes)

The patient should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Suvardio Plus

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.

The expiry date refers to the last day of the month stated.

The medicine should be stored in its original packaging to protect it from light. There are no special storage temperature requirements.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Suvardio Plus contains

The active substances of Suvardio Plus are rosuvastatin (in the form of calcium salt) and ezetimibe.

Suvardio Plus, 5 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.

Suvardio Plus, 10 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.

Suvardio Plus, 20 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone type A, povidone K-30, sodium lauryl sulfate, and magnesium stearate.

What Suvardio Plus looks like and contents of the pack

Suvardio Plus, 5 mg + 10 mg

White or almost white, round, flat uncoated tablets with "E2" engraved on one side and "2" on the other side, with a diameter of 10 mm.

Suvardio Plus, 10 mg + 10 mg

White or almost white, oval, biconvex uncoated tablets with "E1" engraved on one side and "1" on the other side, measuring 15 mm x 7 mm.

Suvardio Plus, 20 mg + 10 mg

White or almost white, round, biconvex uncoated tablets with a diameter of 11 mm.

The tablets are packaged in blisters made of PA/Aluminum/PVC/Aluminum foil and placed in a cardboard box.

Package sizes:

30 or 60 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Adamed Pharma S.A.

ul. Marsz. Józefa Piłsudskiego 5

95-200 Pabianice

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana, Slovenia

For more information about this medicine and its authorized names in the European Economic Area member states, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the leaflet:04/2023

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